Wilder,
I have noticed that Alexion has basically languished during the recent volatility and wondered why. A couple of recent review articles on their lead compounds give clues.
>>Curr Opin Investig Drugs 2002 Jun;3(6):870-7 Pexelizumab Alexion.
Whiss PA.
Faculty of Health Sciences, Department of Medicine and Care, Linkoping Universitet, Sweden. per.whiss@hul.liu.se
Alexion and Procter & Gamble (P&G) are developing pexelizumab (h5G1.1-SC), a short-acting, recombinant complement C5 inhibitor for the potential treatment of complications of cardiovascular surgery, such as complement activation during cardiopulmonary bypass (CPB) procedures, for which it has completed phase II trials [275707]. By November 2001, the companies were also conducting two phase II trials for the treatment of acute myocardial infarction (MI) and by March 2002, patient accrual in the first of these MI trials (COMPLY) had been completed [429171], [443067]. In April 2002, accrual in the second MI trial (COMMA) was also completed [446377]. Results from the MI trials had been expected in the first half of 2002 [435888]. By January 2002, pivotal phase III trials had been initiated in patients undergoing coronary artery bypass graft (CABG) with CPB [435058]. The compound may also have potential in the treatment of stroke [188595]. In September 2000, the US FDA granted Alexion Fast Track status for pexelizumab for CPB patients [381531]. The company is collaborating with P&G to develop and commercialize this inhibitor drug for patients undergoing CPB during CABG [313015]. In December 2001, the terms of the collaboration were altered and as a result Alexion was to play an increased role in the development and marketing of pexelizumab in the US [433296]. Alexion licensed the complement protein C5 technology from Enzon Inc, developed during Enzon's short chain antigen binding (SCA) proteins program, in May 1996 [352743]. Analysts at US Bancorp Piper Jaffray predicted in January 2002 that pexelizumab has potential peak sales of US $350 million. At this time, approval for the CPB indication was expected in the US in the second half of 2004, and sales in 2005 were expected to reach US $50 million, rising to US $227 million in 2008. In the rest of the world, CPB approvals were expected to begin in the second half of 2005. Sales in 2006 were expected to reach US $35 million, rising to US $110 million in 2008 [438051].<<
>>Curr Opin Investig Drugs 2002 Jul;3(7):1017-23
Eculizumab (Alexion).
Kaplan M.
University of Michigan Medical Center, Division of Rheumatology, Ann Arbor 48109-1065, USA. makaplan@umich.edu
Eculizumab (5G1.1), a humanized monoclonal antibody that prevents the cleavage of human complement component C5 into its pro-inflammatory components, is under development by Alexion as a potential treatment for several chronic inflammatory diseases, including rheumatoid arthritis (RA) and nephritis [190673], [292328]. In January 2002, a phase IIb trial was initiated for RA [437814]. This trial was ongoing in April 2002, at which time, eculizumab was also in phase II trials for the treatment of membranous nephritis and lupus nephritis, and in earlier stage clinical trials for dermatomyositis and pemphigoid [446377]. The company is also developing a single-chain version of this antibody, pexelizumab, for use in acute cardiovascular indications [188760]. In October 2000, eculizumab was granted Orphan Drug status by the FDA for the treatment of dermatomyositis [385057]. In February 2002, the product received Orphan Drug designation for its use in patients with membranous nephritis [440583]. In September 2001, analysts at US Bancorp Piper Jaffray predicted eculizumab's launch for dermatomyositis and pemphigus in 2003, RA and nephritis in 2004, and chronic heart failure (CHF) after 2006 [426537]. In March 2002, analysts at US Bancorp Piper Jaffray predicted that the product would have peak worldwide sales in RA of US $175 million and US $400 million for nephritis. Sales for the RA indication are predicted to reach US $35 million in 2006, rising to US $110 million in 2008, and US $10 million in 2006, rising to US $50 million in 2008, in the US and the rest of the world, respectively. For the nephritis/other indication(s), sales are pegged at US $50 million in 2006, rising to US $200 million in 2008, and US $15 million in 2006, rising to US $100 million in 2008, again in the US and the rest of the world, respectively [446992].<<
emphasis mine
I note the use of the words "had been expected." The results are still not in? Do you have a feel for upcoming news timelines here? Seems as though the RA trial might be wrapping up soon, too. Do you or MZ assign odds of success to any of the upcoming trial results?
TIA & Cheers, Tuck |
